Comparative Effectiveness PTSD Trial of Sequenced Pharmacotherapy and Psychotherapy in Primary Care, 11 U.S. States, 2021-2024 (ICPSR 39425)
Based on the state of the scientific evidence, the Sequenced Treatment Effectiveness for Posttraumatic Stress (STEPS) Trial was designed to address three specific aims. The first aim was to quantitatively compare engagement, self-reported PTSD symptom severity (primary outcome), quality of life, and recovery outcomes of primary care patients randomized to initially receive brief psychotherapy (Written Exposure Therapy - WET) or their choice of the three selective serotonin reuptake inhibitors (SSRIs). The second aim was, among patients not responding to initial treatment, to quantitatively compare outcomes of primary care patients randomized to: 1) augment the SSRI with WET, 2) switch from the SSRI to another class of antidepressants (serotonin-norepinephrine reuptake inhibitors - SNRI), or 3) switch from WET to the choice of the three SSRIs. The third specific aim was to quantitatively examine treatment heterogeneity among subgroups of primary care patients receiving pharmacotherapy and psychotherapy, including veterans, women, and those using cannabis.
Design and Methodological Improvements for Patient-Centered Small n Sequential Multiple Assignment Randomized Trials (snSMARTs) in the Setting of Rare Diseases [Methods Study], 2016-2020 (ICPSR 39636)
A rare disease is one that affects fewer than 200,000 people in the United States. Because few people have these diseases, clinical studies on treatments can be hard to conduct. One way to study rare disease treatments is with an snSMART study.
snSMART studies have two stages. In the first stage, researchers assign patients to a treatment by chance. In the second stage, patients may stay with the same treatment or switch treatments. Patients stay on the same treatment if it's working well. If the treatment isn't working, researchers assign patients by chance to a new treatment.
snSMARTs can help researchers learn more from a smaller number of patients than a standard clinical study. But most current methods for analyzing snSMARTs use data only from the first stage, which can lead to inefficient results.
In this project, the research team developed and tested new methods that use data from both stages to analyze snSMARTs. The team compared results from the new methods to actual treatment effectiveness to see Bias, or whether results are too high or too low effficiency, or how big the difference is between the results and actual treatment effectiveness
To access the software, please visit the snSMART Sample Size App.